Indian API Manufacturers remain in the Focus of European GMP Inspectors

Some time ago three Non-Compliance Reports have been published in quick succession in the EudraGMDP database. Those reports deal with inspections performed at pharmaceutical APIs production sites located in India. Read more about the fundamental violations of the requirements for GMP-compliant API manufacturing in those facilities.

http://www.gmp-compliance.org/enews_05414_Indian-API-Manufacturers-remain-in-the-Focus-of-European-GMP-Inspectors_15339,15332,S-WKS_n.html

The EudraGMDP database contains more and more frequently Non-Compliance Reports of API facilities located in India. Three of these reports were published in April and May this year. The companies inspected (Krebs Biochemicals & Industries Ltd, J P Laboratories Private Ltd and Dhanuka Laboratories Ltd) were accused of major violations of the GMP rules (in one case even a critical violation was observed). All in all, the GMP inspectors came to the conclusion that – in their current states – those facilities are not able to manufacture APIs in a GMP-compliant way.

At all three companies, deficiencies against the fundamental requirements for GMP-compliant…